BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY DR, DF-4 CONNECTOR

    MDR report key: 4133719 · Received October 1, 2014

    Report

    Report Number
    2938836-2014-16284
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 21, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVING INAPPROPRIATE ATP THERAPY DUE TO AF WITH RAPID VENTRICULAR RESPONSE. AN ALERT FOR LOW HIGH VOLTAGE LEAD IMPEDANCE WAS OBSERVED. THERAPIES WERE DISABLED AND THE PATIENT WAS FITTED WITH A LIFE VEST UNTIL FOLLOW-UP WITH THEIR OWN CARDIOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611081 FORTIFY DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 7120Q/58, BNP016236